Kornimate/medical-research-clean huggingface dataset:
efficacy and safety study of nasal lubricant compared to placebo on snoring

Conditions: Snoring; Sleep Disorder

Summary: pivotal clinical trial, multicenter of superiority, randomized, double-blind, parallel groups, placebo-controlled and use of nasal lubricant on snoring.

this study is designed for the improvement of snoring, characterized by a noise caused by the vibration of tissues obstructing the nasopharynx and oropharynx during sleep. it is performed in participants of both sexes, over 18 years of age, who complain of snoring. the rationale for studying the use of a medical device with nasal spray solution for snoring improvement is due to the fact that surface tension in the pharyngeal mucosa plays an important role in determining airway collapsibility.

Eligibility criteria:
inclusion criteria: * have signed the informed consent form; * participants of both genders aged ≥ 18 years; * report of snoring assessed objectively through the standardized criteria in the snoring noise domain in the berlin questionnaire; exclusion criteria: * history of allergy or hypersensitivity to the components of the nasal lubricant; * fixed nasal obstruction; * upper airway infections active or present for less than 7 days; * use of benzodiazepines and sleep inducing drugs; * under treatment for sleep apnea of any modality currently or within the past 6 months; * hepatic insufficiency; * active neoplastic disease; * severe sleep apnea determined by polysomnography (ahi \> 30); * moderate sleep apnea with presence of excessive daytime sleepiness; * clinically significant illness or surgery, at the discretion of the principal investigator, within 30 days prior to study inclusion; * history of chemical dependence or alcohol abuse; * any neurological and psychiatric disease or significant laboratory finding present, unless adequately controlled with medication allowed in the protocol; * patients with laboratory tests of sgot, sgtp or cpk increased by at least two times the upper value of normal at the time of study inclusion; * women who are pregnant or breastfeeding or who have the desire to become pregnant; * history of infarction and stroke; * craniofacial malformation; * bmi \> 35 kg/m2; * ido ≥ 30 events/h determined in residence by biologix®; * have symptoms of covid-19 (fever, cold, loss of smell, loss of taste, dry cough, sore throat, diarrhea, difficulty breathing, fatigue, body aches and pains, headache).

Keywords: nasal lubricant sleep medical device
percutaneous pin removal in children - is analgesia necessary?

Conditions: Elbow Fracture

Summary: this is a simple randomised clinical trial to study if non-narcotic analgesia reduces the pain score and pulse rate of children who undergo removal of percutaneous pins in the outpatient clinic. inclusion criteria: * 5-12 years of age * 2 or 3 percutaneous pins in either elbow exclusion criteria: - documented or suspected allergies to acetaminophen, ibuprofen patients enrolled in the study are instructed not take additional analgesia prior to the clinic visit (risk of overdosage explained). this is verified by clinic nurses conducting the trial. at the clinic visit, they are randomized into one of three groups 1. acetaminophen; 2. ibuprofen; or 3. vitamin c (placebo). they are served the 'medication' (weight-appropriate dose) and the pins are removed in the clinic an hour later. pain score (wong-baker scale) and pulse rate are measured before pin removal, immediately following pin removal, and 10 minutes after pin removal. the study hypothesis is that non-narcotic analgesia (such as acetaminophen and ibuprofen) do not decrease pain score and pulse rate associated with the pin removal procedure.

see brief summary

Eligibility criteria:
inclusion criteria: * age: 5-12 inclusive * 2 or 3 percutaneous pins in either elbow exclusion criteria: * documented or suspected allergies to acetaminophen or ibuprofen

Keywords: children supracondylar fracture pin removal analgesia pain score
effects of periodized and autoregulated resistance training in haematological cancer patients during the treatent.

Conditions: Fatigue; Leukemia; Lymphoma; Physical Disability

Summary: several clinical trials have demonstrated the positive impact of physical functioning and fatigue in patients who received training programs during the myeloablative chemotherapy with stem cell transplantation. however, the heterogeneity among the forms of physical activity results in moderate to very low evidence available about benefits of physical exercise. in this randomized and controlled clinical trial, we will study the effects on physical performance and fatigue of periodic resistance training programs, with an autoregulated approach within a non-linear model, based on the individual patient response to cancer treatment.

the sample will consist of 66 patients diagnosed with leukemia and lymphoma undergoing high-dose chemotherapy, with or without hematopoietic stem cell transplantation, who will be randomized into two groups. the physical performance and fatigue outcomes will be compared between the control and the experimental group. the control group will perform an exercise program based on the standard protocol of physical therapy, consisting of bicycle ergometer endurance training for 5 minutes, with resistance individually adjusted based on the patient's feedback (from 70% of maximum heart rate) and resistance exercises for muscle groups hip flexors, knee extensors and ankle plantar flexors and resistance training form arms, with weigths of 0,5 to 1,0 kg (10 repetitions, 1 set). the experimental group will perform a periodic resistance training program, with an auto-regulated and a non-linear model, using the submaximal ergometer tests with incremental load (from 85% of maximaum heart rate or maximum effort related), 30-second chair stand, hand grip strenght and submaximal effort of arms with weights of 0,5 to 1,0 kg.

Eligibility criteria:
inclusion criteria: * patients clinically diagnosed with leukemia or lymphoma, in the first or second line of treatment, undergoing high-dose chemotherapy, with or without hematopoietic stem cell transplantation; * neurological and cognitive functions preserved; * physical conditions that enable participation in physical rehabilitation. exclusion criteria: * clinical complications that contraindicate physical therapy exercises, including the practice of cycle ergometer and resistance exercises; * previous musculoskeletal alteration that interferes in physical performance evaluation tests; * recent cardiovascular or pulmonary disease; * psychiatric or neurological disorder; * inability to walk on its own or presence of bone metastasis; * adherence on less than 50% of the total sessions of the study.

Keywords: fatigue physical therapy hematological malignancy
a study to compare health care costs between apixaban and low molecular weight heparin in patients with venous thromboembolism and cancer

Conditions: Thromboembolism

Summary: the purpose of this study is to evaluate the health care resource utilization and costs associated with treating patients diagnosed with cancer and venous thromboembolism with apixaban or low molecular weight heparin. this is a retrospective database analysis of health care claims data. all-cause costs as well as costs associated with recurrent vte, major bleeding, and clinically relevant nonmajor bleeding will be assessed.


Eligibility criteria:
inclusion criteria: * venous thromboembolism (vte) diagnosis between january 1 2017 and october 31 2021 * evidence of active cancer * at least 1 claim for apixaban or low molecular weight heparin (lmwh) * age 18 years or older exclusion criteria: * diagnosis of atrial fibrillation/flutter * procedure for mechanical heart valve or inferior vena cava filter * vte diagnosis in the baseline period * anticoagulant therapy in the baseline period * pregnancy
effect of a concurrent physical exercise program in hemodialysis patients

Conditions: Chronic Renal Insufficiency; Hemodialysis

Summary: concurrent physical exercise is the method of combining strength and endurance that can be worked with in one session or in an exercise program. therefore, the researchers seek to implement it in patients suffering from chronic renal failure with hemodialysis therapy and see if concurrent physical exercise improves quality of life levels and at the same time see the response of physical fitness, body composition and biochemistry.

introduction: the performance of physical exercise has positive effects in terms of quality of life, but when it is not performed consistently it triggers a sedentary lifestyle, which is reflected in overweight and obesity, in addition to developing chronic noncommunicable diseases, propitiating chronic kidney disease, which although, hereditary and environmental factors are also present in this pathology and as the disease progresses, chronic renal failure develops. objective: to analyze the effect of a concurrent physical exercise program on quality of life in patients with chronic renal failure undergoing hemodialysis. methods: uncontrolled clinical trial in which a concurrent physical exercise program will be carried out for 6 weeks, performing physical evaluations such as 6-minute walk and manual strength by dynamometer, application of sf-36 questionnaires, measurement of urea, glucose, creatinine and albumin, in addition to analyzing body composition by electrical bioimpedance.

Eligibility criteria:
inclusion criteria: * patients who are cared for at the state hemodialysis center. * receive hemodialysis treatment 3 times per week. * sign the informed consent form. exclusion criteria: * patients under 18 years of age. * patients with a history of fracture at less than 2 months of evolution. * patients with any rheumatologic disease (lupus or rheumatoid arthritis). * prostrate patients. * amputee patients. * positive patients (hiv). * uncontrolled comorbidities. elimination. * patients who make their voluntary withdrawal from the project. inability to engage in physical exercise. * death.

Keywords: hemodialysis functional capacity physical exercise quality of life
comparison of biliary stenting alone vs. stenting with photodynamic therapy (pdt) during ercp

Conditions: Cholangiocarcinoma

Summary: this study entails retrospective and prospective review of data from a database protocol. data gathered will be then analyzed for a set amount of patients. in this study, the investigators will compare biliary stenting vs. biliary stenting plus photodynamic therapy (pdt) and assess if pdt can improve quality of life and prolong survival.

successful palliation of biliary obstruction is the main goal for reducing morbidity and mortality in patients with biliary disease and biliary obstruction related to cholangiocarcinoma. surgical biliary bypass is unfortunately complicated by a 30-day postoperative mortality rate of between 7 and 24%. moreover, because of recovery time the quality of life following surgery is only improved in a minority. at present endoscopic insertion of a plastic or metal stent is the method of choice to relieve obstructive jaundice without the high morbidity and mortality associated with surgery. but this relief is unfortunately temporary since stents tend to become obstructed and the fact that effective biliary drainage in the proximal lesion is challenging. photodynamic therapy (pdt) is a new therapeutic approach that specifically targets neoplastic cells. this therapy involves the intravenous administration of a photosensitizing agent followed by activation of the agent by illumination with non-thermal light of a specific wavelength, resulting in cell death from direct cytotoxicity and ischemic necrosis. cytotoxicity is directly proportional to tissue oxygenation. a prospective, randomized and controlled trial study by ortner et all confirmed the significant advantage of pdt with regard to relief of jaundice, quality of life, and survival. the improvement of survival in the randomized pdt group was so impressive that it was believed unethical to continue with randomization after the first 39 patients (20 and 19 in each group).previously, the principal investigator conducted such a study (and also conducted endoscopic retrograde cholangiopancreatography with pdt) at the university of virginia, and would continue to conduct these procedures, as well as the study at wcmc.

Eligibility criteria:
inclusion criteria: * any patient who has undergone ercp (endoscopic retrograde cholangiopancreatography) and biliary stenting with or without photodynamic therapy. * biliary disorder or obstruction due to cholangiocarcinoma. * above 18 years of age. exclusion criteria: * any patient who has not undergone ercp and biliary stenting. * not diagnosed with cholangiocarcinoma. * below 18 years of age

Keywords: cholangiocarcinoma pdt photodynamic therapy bile duct bile duct obstruction jaundice biliary stent ercp obstructive jaundice
effect of green tea extract on lipids in patients with type 2 diabetes

Conditions: Diabetes Mellitus, Type 2; Dyslipidemias; Arterial Stiffness

Summary: the main objectives of this study were to evaluate the effect of a 12-week supplementation with gte (400 mg every 12 hours) on serum lipids, arterial stiffness and inflammatory cytokines in patients with t2dm.

a 12 week randomized double-blind, placebo-controlled trial was conducted in patients with t2dm to evaluate the effect of green tea extract (sunphenon 90d, taiyo international, minneapolis, us) at a 400 mg/12 hrs dose or calcined magnesia (400 mg/12 hrs) on lipids, anthropometric variables, arterial stiffness and inflammatory cytokines.

Eligibility criteria:
inclusion criteria: - patients with type 2 diabetes exclusion criteria: * type 1 diabetes * smoking patients * ischemic heart disease * use of anti-inflammatory or antioxidant drugs * previously diagnosed liver or thyroid disease
lymfit to improve the fitness and quality of life in lymphoma survivors

Conditions: Lymphoma; Cancer Survivors

Summary: this randomized control trial seeks to determine whether a tailored and supervised exercise program adopting mobile-health technology will be able to improve fitness and quality of life among lymphoma survivors.

lymphoma is the most common cancer diagnosed in young adults. while curing 80% of patients, lymphoma treatment has a significant impact on young adults' health and psycho-social wellbeing by increasing fatigue and anxiety, risk of cardiovascular disease and other chronic disorders, all of which compromise one's quality of life. regular exercise has the potential to reduce the side effects associated with cancer treatments. thus, the most recent guidelines suggest that cancer patients should engage in adapted exercise programs during and after their treatment. however, these guidelines are not systematically recommended by doctors and are often not followed by patients. fatigue and lack of motivation are the main barriers to exercise among cancer survivors. our study aims to identify young adults lymphoma patients and encourage them to adhere to the exercise guidelines with the help of an exercise physiologist and a fitness tracker. the investigators will evaluate the efficacy of these strategies in motivating exercise among young adults lymphoma survivors. our proposed study carries significant implications for the prevention of complications of treatment for young adults lymphoma survivors.

Eligibility criteria:
inclusion criteria: 1. newly diagnosed lymphoma patients who received an initial diagnosis at the age of age 18-39, 2. approved by their hematologist as having no contra-indications to vigorous exercise, 3. receiving or has received chemotherapy with curative intent within the past 6 months, 4. own a cellular phone that is able to download the fitbit app and to complete the study questionnaires online in either french or english, and 5. has an internet connection at home that supports participation in coaching sessions via videoconferencing (zoom). exclusion criteria: 1. the patient has contra-indications to vigorous exercise, 2. the patient doesn't want to wear a fitness tracker due to various concerns (as no fitbit data could be collected).

Keywords: cancer survivorship quality of life physical activity fear of recurrence randomized controlled trial
contribution of nuclear magnetic resonance imaging in the study of diabetic cardiomyopathy

Conditions: Diabetic; Cardiomyopathy

Summary: diagnosis of diabetic cardiomyopathy is then retained, supposing a change in the coronary microcirculation linked to an endothelial dysfunction. abnormalities of the myocardial metabolism is frequently associated. it is regrettably about a hypothesis difficult to verify with current medical techniques.this deficiency being not only harmful to the diagnosis, but also to the assessment of the efficiency of the medical treatment on the myocardial metabolism and the endothelial function. techniques of nuclear magnetic resonance offer interesting perspectives.

these techniques allow in this context: 1. to quantify the myocardial blood flow at rest and after "cold pressor test" in a population of healthy volunteers. the myocardial blood flow will be obtained by estimating myocardial blood flow at the venous coronary sinus site. this allows us to quantify a possible endothelial dysfunction in a reproducible way. no mri study in diabetic patients has ever been led until now with this technique. 2. to estimate the metabolic and structural abnormalities in this population, with particularly: * quantification of the myocardial metabolism in vivo by spectrometry of phosphorus 31. * structural abnormalities: become integrated into the description of diabetic cardiomyopathy.

Eligibility criteria:
inclusion criteria: * more than 18 years old * patient type 2 diabetes affects taken care more than 5 years to timone hospital * patient with a diabetic cardiomyopathy * informed and consented exclusion criteria: * less than 18 years * pregnant woman * patient type 1 diabetes affects * patient presents a cardiomyopathy mixed (no diabetic) * patients presents an arrhythmia ventriculaire or above - ventriculaire * unstable hémodynamique patients

Keywords: type 2 diabetes cardiovascular diseases coronary syndrome have abnormalities of glucidic metabolism
a study to compare pk, pd and safety of the ad-213-b and ad-2132

Conditions: Gastroesophagus Reflux Disease

Summary: a study to compare safety, pharmacokinetics and pharmacodynamics of ad-213-b to ad-2132 in healthy volunteers.


Eligibility criteria:
inclusion criteria: * healthy adults over 19 years of age. * weight is more than 50kg and bmi is more than 18.0 kg/m\^2 , no more than 27.0 kg/m\^2. * subject who has been judged to be eligible for clinical laboratory tests and electrocardiogram tests such as serum tests, hematology tests, blood chemistry tests, and urinary tests conducted within four weeks prior to the administration of clinical trials. * subjects who has heard and fully understood the detailed description of this clinical trial and have willingness to sign of informed consent in writing. exclusion criteria: * a subject who has a history that can affect the absorption, distribution, metabolism, or excretion of a drug. * as a result of laboratory tests, the following figures: alt or ast or total bilirubin \> 1.5 times upper limit of normal range. * as a result of laboratory tests, the following figures: creatinine clearance \< 80ml/min. * subjects who judged ineligible by the investigator.
first in men study of single oral doses of asp1941 in healthy subjects

Conditions: Healthy

Summary: this study determined the safety, tolerability, pharmacokinetics (pk) and pharmacodynamics (pd) of asp1941 after a single oral dose (part a). in addition, it was investigated whether the intake of food had an effect on the pk of asp1941 (part b).

this study consists of two parts. part a is a double-blind, placebo controlled single dose escalation study to evaluate the safety and tolerability of single ascending doses of asp1941. part b is an open label, crossover design food-effect study to evaluate the effect of fed conditions on the pk of asp1941.

Eligibility criteria:
inclusion criteria: * body weight between 60-100 kg, body mass index (bmi) between 20-30 kg/m2, inclusive exclusion criteria: * fasting plasma glucose (fpg) \> 6.4 mmol/l * hba1c \> 6.2% * pulse \ 90 beats per minute; systolic blood pressure (sbp) \ 140 mmhg; diastolic blood pressure (dbp) \ 95mmhg

Keywords: asp1941 diabetes mellitus first in men
ehealth-based cardiac rehabilitation in post-myocardial infarction patients

Conditions: Myocardial Infarction

Summary: the goal of this randomized controlled trial is to compare the effect of ehealth-based cardiac rehabilitation with the effect of usual care on exercise capacity and qualify of life in patients after myocardial infarction.

cardiac rehabilitation can improve exercise capacity, life of quality, readmission rate and mortality rate for patients after myocardial infarction. international guidelines list cardiac rehabilitation after myocardial infarction as class ia recommendation. however, low participation rate of cardiac rehabilitation due to barriers such as lacking of time, transport or affordability issues is an unsolved problem worldwide. ehealth, consisting of telemedicine, mobile health and personalized care using wearable devices has the potential to remove the barriers and become an effective model to deliver cardiac rehabilitation. thus, we design a randomized controlled trial to compare the effect of a case manager-led ehealth-based cardiac rehabilitation program with usual care on the compliance, physical activity, quality of life, and cardiorespiratory fitness in patients after myocardial infarction.

Eligibility criteria:
inclusion criteria: 1. ≥ 20 years of age. 2. within 6 months after the onset of acute myocardial infarction. 3. at lowest to moderate risk according to the guideline from american association of cardiovascular and pulmonary rehabilitation. 4. unable or refused to attend center-based cardiac rehabilitation. exclusion criteria: 1. unable to walk independently or use a stationary bike. 2. unable to follow verbal command. 3. not having a smartphone which can get on the internet. 4. having contraindications for exercise according to american college of sports medicine's guidelines for exercise testing and prescription. 5. unable to provide informed consent.

Keywords: cardiac rehabilitation telerehabilitation myocardial infarction